Open Surgery Group Research Articles

Short-term efficacy of open surgery versus arthroscopic rotator cuff repair in moderate rotator cuff tears.

To evaluate the clinical efficacy of open versus arthroscopic rotator cuff repair in treating moderate rotator cuff tears. A retrospective study was conducted on 68 patients diagnosed with moderate rotator cuff tears and who were treated surgically at Hangzhou Fuyang Hospital of Traditional Chinese Medicine Orthopedics and Traumatology from September 2021 to April 2023. Patients were categorized based on the surgical methods they received: the minimally invasive group (MIG, n=37, undergoing arthroscopic rotator cuff repair) and the open surgery group (OSG, n=31, undergoing open rotator cuff repair). Operative indicators, perioperative and follow-up pain intensity, shoulder joint scores, range of motion, and complication incidence were compared between the two groups. Additionally, the factors affecting prognosis were also analyzed. The MIG had shorter operative time, shorter hospital stay, smaller incision length, and less intraoperative blood loss than the OSG (all P<0.05). At 6 weeks and 3 months postoperatively, the MIG reported significantly lower Visual Analogue Scale (VAS) scores and higher Constant-Murley scores compared to the OSG (all P<0.05). At the 6-month follow-up, the MIG exhibited higher University of California-Los Angeles scores and Constant scores, as well as greater forward flexion, abduction, and lateral rotation angles than OSG (all P<0.05). The incidence of complications was lower in the MIG compared to the OSG (P<0.05). The binomial logistic regression analysis identified surgical approach as an independent risk factor for postoperative complications (P<0.05). Arthroscopic rotator cuff repair for patients with rotator cuff tears involves minimal trauma and allows for rapid postoperative recovery. Additionally, the procedure helps restore shoulder joint function and improve the range of motion, offering promising clinical applications.

Comparison of radiofrequency ablation and surgery for thyroid papillary microcarcinoma: efficacy, safety and life quality.

To compare the efficacy, safety and patients' quality of life of radiofrequency ablation (RFA) and surgery in the treatment of papillary thyroid microcarcinoma (PTMC). MEDLINE, EMBASE, Cochrane, CNKI and other databases were searched for studies on radiofrequency ablation versus traditional surgery for PTMC up to October 2022. RevMan5.4 software was used for Meta-analysis. 10 articles were selected from 392 articles, including 873 cases of radiofrequency ablation and 781 cases of open surgery. After meta-analysis, the incidence of postoperative complications in the radiofrequency ablation group was lower than that in the surgery group, and the difference was statistically significant [OR=0.24, 95%CI (0.14,0.41), P<0.001]. There were no significant differences in lymph node metastasis rate, local recurrence rate, and new tumor rate between the two groups [OR=1.6, 95%CI (0.21, 12.41), P>0.05; OR=0.85, 95%CI (0.05, 13.8), P>0.05; OR=0.12, 95%CI (0.01, 0.98), P>0.05]. The treatment time and hospital stay in the radiofrequency ablation group were shorter than those in the open surgery group [MD=-49.99, 95%CI (-62.02, -37.97), P<0.001; MD=-5.21, 95%CI(-7.19,-3.23),P<0.001], and the cost was significantly lower than that of the traditional surgery group [SMD=-14.97, 95%CI (-19.14, -10.81), P<0.001]. The quality of life of patients in the radiofrequency ablation group was higher than that in the surgery group [MD=-1.61, 95%CI (-2.06, -1.17), P<0.001]. Compared with traditional open surgery, radiofrequency ablation for papillary thyroid microcarcinoma has the advantages of less trauma, fewer complications, faster recovery and higher quality of life. The indications need to be strictly controlled in the treatment. https://www.crd.york.ac.uk/PROSPERO/, identifier (CRD42022374987).

Isolated posterior stabilization in type B and C thoracolumbar fractures associated with ankylosing spine disorders: A single center experience with clinical and radiological outcomes.

Fractures in ankylosing spine disorders (ASD) are associated with high complication and mortality rates. During the posterior stabilization of these fractures, reduction is often partial, resulting in the persistence of a significant anterior diastasis. Our objective was to evaluate the safety and efficiency of isolated posterior stabilization in elderly ASD patients, without direct reduction of the anterior diastasis, in terms of clinical and radiological outcomes, complications, and mortality. This retrospective study included 46 patients, mean age 79.3years, with ASD, who underwent isolated posterior stabilization, open or percutaneous, for thoracolumbar fractures. The average follow-up was 21.7months, with a minimum follow-up of 6months. Autonomy (Parker score) and radiological results (lordotic angulation) were analyzed pre-and post-operatively. Autonomy was maintained at the last follow-up, with no significant difference in Parker's score. The consolidation rate was 94.6%. No implant failure was recorded. Despite the absence of an anterior procedure, lordotic angulation was significantly reduced by 2.6° at 6months (p=0.02). The rate of surgical complications following open surgeries was 10.9% (n=5), of which 6.5% were infections. No surgical complications were reported in percutaneous surgeries. The rate of medical complications was 67.4% (n=31), with a rate of 88.2% in the open surgery group, compared to 55.2% in the percutaneous surgery group. An open approach was associated with a five-fold higher risk of complications (p=0.049). Nine patients died during follow-up (19.6%). Isolated posterior stabilization in the treatment of thoracolumbar spine fractures in elderly ASD patients is a safe technique promoting autonomy preservation, and high radiological bony healing with acceptable complication and mortality rates. The persistent anterior gap is partially reduced when the spine is loaded and does not seem to require an anterior procedure, thus decreasing complications. Percutaneous surgery should be the technique of choice to reduce surgical complications.

Application value of laparoscopic surgery in elderly patients (≥ 75 years) with colorectal cancer and prognostic factors influencing 5-year overall survival.

To investigate the application value of laparoscopic surgery in elderly patients (≥ 75 years) with colorectal cancer, and to identify the prognostic factors influencing the long-term survival in this demographic, and to establish a predictive nomogram model. A retrospective analysis was conducted on 146 elderly (≥ 75 years old) colorectal cancer patients who underwent radical surgery in Baoji People's Hospital from August 2016 to February 2018, including 55 patients who underwent laparotomy and 91 patients who underwent laparoscopic surgery. Survival curves were plotted using the Kaplan-Meier method, and differences in prognosis were assessed using the Log-rank test. Prognostic impacts of various factors on 5-year survival were analyzed using a Cox proportional hazards model. Significant predictors identified in the Cox model were used to construct a nomogram for predicting survival, which was then validated for accuracy and clinical utility. Laparoscopic surgery was associated with shorter hospital stays (P = 0.022), although at a higher cost (P = 0.011). The laparoscopic group also had less intraoperative bleeding (P < 0.001), incision length (P < 0.001), time to first postoperative expectoration (P < 0.001), time to first postoperative feeding (P = 0.002), and time to postoperative peritoneal drainage (P = 0.003) compared to the open surgery group. Additionally, the rate of postoperative wound complications was also lower in the laparoscopic group (P = 0.014). There was no significant difference in the 5-year post-treatment survival between the two groups (P = 0.150). Multifactorial Cox regression analysis revealed that a history of diabetes mellitus (P = 0.037), vascular infiltration (P = 0.026), nerve bundle invasion (P = 0.001), and TNM stage (P = 0.001) were independent prognostic factors affecting the 5-year survival of patients with advanced colorectal cancer. The constructed nomogram showed high predictive accuracy for 1-, 3-, and 5-year survival, with AUC values of 0.91, 0.87, and 0.79, respectively. Calibration curves and decision curve analysis confirmed the model's clinical utility. Risk formula: History of diabetes mellitus * -0.696194503 + Vascular infiltration * -0.769736513 + Nerve bundle invasion * -1.1709777 + TNM staging * 1.201933691. Laparoscopic surgery can reduce intraoperative trauma and accelerate postoperative recovery in elderly colorectal cancer patients (≥ 75 years) compared to open surgery. The developed nomogram model based on independent prognostic factors such as diabetes history, vascular infiltration, nerve bundle invasion, and TNM staging, facilitates tailored prognostic assessment, enhancing individual patient management.

Comparative analysis of the effects of limbal and adipose‐derived mesenchymal stem cell conditioned media on oxidative stress‐induced damage in retinal pigment epithelial cells

Aims/Purpose: The purpose of this investigation was to evaluate the impact of adipose and limbal tissue‐derived mesenchymal stem cell‐conditioned media on survival, and inflammation in H2O2‐induced retinal pigment epithelial cells.Methods: Following national regulations and with the approval of the Koç University Ethics and Investigation Committee, human limbal (L) and adipose‐derived (Ad) mesenchymal stem cells (MSCs) were isolated from cadaveric corneaoscleral rims from donors that originated from the cornea bank of Ministry of Health in Turkey and adipose tissue from discarded human liposuction surgery specimens, respectively. Conditioned medium (CM) that obtained by culturing MSCs in absence of serum was concentrated by filtration. Following a 24‐h pre‐treatment with H2O2, retinal pigment epithelial (RPE) cells were treated with MSC‐CM. Groups were defined as follows: Control, H2O2‐treatment (OS), OS‐Basal Medium, OS‐AdMSC‐CM and OS‐LMSC‐CM. Cell viability was assessed using MTT assay. Gene expression levels of pro‐ and anti‐inflammatory cytokines were analysed by qRT‐PCR.Results: Based on MTT assay, H2O2 inhibited the growth of RPE cells with IC50 values of 150 μM at 24 h. We found that MSC‐CM attenuated H2O2‐induced loss of cell viability. In comparison to the OS group, the LMSC‐CM and AdMSC‐CM treatments demonstrated significantly decreased levels of IL‐6, IL‐8, IL‐10 and TGF‐β1 gene expression.Conclusions: MSC‐CM ameliorated H2O2‐induced retinal pigment epithelial cell damage by alleviating inflammation.

Therapeutic Prediction of Osteoporotic Vertebral Compression Fracture Using the AO Spine-DGOU Osteoporotic Fracture Classification and Classification-Based Score: A Single-Center Retrospective Observational Study.

The treatment of osteoporotic vertebral compression fractures (OVCFs) is based on their severity; however, an efficient prediction tool is lacking. We aimed to evaluate the validity of the osteoporotic fracture classification (OF classification) and scoring system (OF score) in predicting the treatment strategy for patients with OVCF, defined according to the Japanese criteria. We retrospectively investigated 487 consecutive patients diagnosed with vertebral body fractures between January 2018 and December 2022. Only patients with their fresh vertebral fracture episode during the study period were included. Patients were classified into 3 groups: conservative treatment, balloon kyphoplasty (BKP), and open surgery. OF classification and OF scores were assessed for each patient. A total of 237 patients with OVCF were included. There were 127, 81, and 29 patients in the conservative, BKP, and open surgery groups, respectively. The OF score was significantly higher in the BKP and open surgery groups than in the conservative group (p < 0.001). Multivariate logistic regression analysis showed that antiosteoporotic drug use, OF classification, progressive deformity, neurological symptoms and mobilization were independent risk factors for operative treatment (all p < 0.001). Receiver operating characteristic analysis showed that the cutoff OF score for operative indication was 5.5, with a sensitivity of 91.9%, specificity of 56.5%, and area under the curve of 0.820 (95% confidence interval, 0.769-0.871). The OF score identified patients who required operative treatment with a high degree of accuracy. This is especially important for ruling out patients who definitely require operative treatment.

A retrospective study comparing minimally invasive versus open surgical resection of small intestinal neuroendocrine neoplasms at a tertiary referral center

IntroductionNeuroendocrine neoplasms (SI-NEN) are the commonest malignancies of the small intestine. Traditionally, surgical treatment for SI-NEN has been open surgery. PurposeThe purpose of this study was to compare minimally invasive surgery (MIS) with the traditional open surgery approach for treating SI-NEN in a Swedish population. MethodsPatients with histopathological confirmed SI-NEN who underwent open surgery or MIS resection within 2009–2021 were extracted from the hospital's medical records. Results65 patients were included in this study, with 35 (54 %) undergoing MIS and 30 (46 %) undergoing open surgery. We found no statistically significant difference (p = 0.173) in the frequency of R0 resections (MIS group n = 34 (97 %), open surgery group n = 26 (87 %)). Nor was there a significant difference (p = 0.101) when comparing the median number of resected lymph nodes (MIS group n = 13.5, open surgery group n = 10). A post-operative paralytic ileus was more often reported (p = 0.052) in the MIS group (n = 9, 26 %) compared to the open surgery group (n = 2, 7 %). In light of this, the days of hospital stay did not differ significantly (MIS group median = 6, IQR (5–8), open surgery group median = 6, IQR (5–9)). The Kaplan-Meier analysis did not reveal differences concerning cancer-related deaths (p = 0.109). ConclusionThe results from this study support that a MIS approach for the treatment of SI-NEN may not be inferior to open surgery. The higher number of resected lymph nodes and R0 resections may even speak in favor for a MIS approach. More studies with a longer time of observation are needed to further support this conclusion.

Exploring Surgical Strategies for Uterine Fibroid Treatment: A Comprehensive Review of Literature on Open and Minimally Invasive Approaches.

Background and Objectives: Uterine myomas represent one of the most prevalent pathologies affecting the female population. These benign neoplasms originate from the smooth muscular cells of the uterus, and they can be either single or multiple. Often associated with debilitating symptoms such as pelvic heaviness, pain, constipation, and urinary dysfunctions, the surgical management of myomectomy exhibits considerable variability. This diversity in approaches is influenced by factors such as the number and size of myomas, the patient's age, and overall clinical conditions. This study aims to elucidate and compare the advantages and disadvantages of different surgical approaches, specifically endoscopic procedures versus open surgery, providing valuable insights for clinical decision making. Materials and Methods: A comprehensive bibliographic search spanning from 2013 to 2023 was systematically conducted across databases including Medline, Embase, the Cochrane Database of Systematic Reviews, and ClinicalTrials.gov. The search utilized keywords such as "myomectomy laparoscopic and open", "myomectomy open and minimally invasive", "myomectomy open and laparoscopic", and "myomectomy open vs. laparoscopic." The research methodology, along with predetermined inclusion and exclusion criteria, was established prior to the search, ensuring a systematic and rigorous approach. Subsequently, data analysis was carried out. Results: Following the study selection process, 25 articles met the eligibility criteria for inclusion in this analysis. The average numbers of myomas were 3.7 (ranging from 1 to 13.7) and 5.4 (ranging from 1 to 13.5) for the minimally invasive surgery and open surgery groups, respectively. In terms of myoma size, the total averages across studies were 7 cm (ranging from 4.8 to 14) for the minimally invasive group and 8 cm (ranging from 3.9 to 11.2) for the open surgery group. The average pregnancy and delivery rates were 29.7% (ranging from 1.8 to 100) for the minimally invasive group and 28.5% (ranging from 1.8 to 100) for the open surgery group. Regarding complications, the average rate was 14.2% (ranging from 0 to 50) for the endoscopic group and 22.3% (ranging from 0 to 60.3) for the laparotomic group. Conclusions: In conclusion, a critical factor influencing the choice of surgical approach is primarily the size and quantity of fibroids. The mini-laparotomic approach emerges as a viable alternative to endoscopy, demonstrating favorable surgical outcomes and aesthetic results. Interestingly, the type of surgical procedure appears to have no significant impact on the pregnancy rate.

Safety and feasibility of laparoscopic radical resection for bismuth types III and IV hilar cholangiocarcinoma: a single-center experience from China.

Surgery represents the only cure for hilar cholangiocarcinoma (HC). However, laparoscopic radical resection remains technically challenging owing to the complex anatomy and reconstruction required during surgery. Therefore, reports on laparoscopic surgery (LS) for HC, especially for types III and IV, are limited. This study aimed to evaluate the safety and feasibility of laparoscopic radical surgery for Bismuth types III and IV HC. The data of 16 patients who underwent LS and 9 who underwent open surgery (OS) for Bismuth types III and IV HC at Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China, between December 2017 and January 2022 were analyzed. Basic patient information, Bismuth-Corlette type, AJCC staging, postoperative complications, pathological findings, and follow-up results were evaluated. Sixteen patients underwent LS and 9 underwent OS for HC. According to the preoperative imaging data, there were four cases of Bismuth type IIIa, eight of type IIIb, and four of type IV in the LS group and two of type IIIa, four of type IIIb, and three of type IV in the OS group (P>0.05). There were no significant differences in age, sex, ASA score, comorbidity, preoperative percutaneous transhepatic biliary drainage rate, history of abdominal surgery, or preoperative laboratory tests between the two groups (P>0.05). Although the mean operative time and mean intraoperative blood loss were higher in the LS group than in OS group, the differences were not statistically significant (P=0.121 and P=0.115, respectively). Four patients (25%) in the LS group and two (22.2%) in the OS group experienced postoperative complications (P>0.05). No significant differences were observed in other surgical outcomes and pathologic findings between the two groups. Regarding the tumor recurrence rate, there was no difference between the groups (P>0.05) during the follow-up period (23.9 ± 13.3 months vs. 17.8 ± 12.3 months, P=0.240). Laparoscopic radical resection of Bismuth types III and IV HC remains challenging, and extremely delicate surgical skills are required when performing extended hemihepatectomy followed by complex bilioenteric reconstructions. However, this procedure is generally safe and feasible for hepatobiliary surgeons with extensive laparoscopy experience.

Changing patterns and surgical outcomes of small bowel obstruction in the era of minimally invasive surgery for colorectal cancer.

This study aimed to investigate whether the incidence, patterns, and surgical outcomes of small bowel obstruction (SBO) have changed in the era of minimally invasive surgery (MIS) for primary colorectal cancer (CRC). Consecutive patients who underwent laparotomy for SBO were divided into MIS and traditional open surgery (TOS) groups based on the previous colorectal cancer operation technique used. The MIS group was selected from 1544 consecutive patients who underwent MIS as a treatment for primary CRCs between 2014 and 2022, while the TOS group was selected from 1604 consecutive patients who underwent TOS as a treatment for primary CRCs between 2004 and 2013. The demographics, clinicopathological features, and surgical outcomes were compared between the two groups. The SBO incidence in patients who underwent MIS for primary CRC was significantly lower than that in patients who underwent TOS (4.4%, n =68/1544 vs. 9.7%, n =156/1604, P <0.0001). Compared with the TOS group, the MIS group had significantly different ( P <0.0001) SBO patterns: adhesion (48.5 vs. 91.7%), internal herniation (23.5 vs. 2.6%), external herniation (11.8 vs. 1.9%), twisted bowel limbs (4.4 vs. 0.6%), ileal volvulus with pelvic floor adhesion (5.9 vs. 1.9%), and nonspecific external compression (5.9 vs. 1.3%). A subset analysis of patients with adhesive SBO (ASBO) showed that the MIS group tended to ( P <0.0001) have bands or simple adhesions (75.8%), whereas the TOS group predominantly had matted-type adhesions (59.4%). Furthermore, SBO in the MIS group had an acute (<3 months) or early (3-12 months) onset (64.7%), while that in the TOS group ( P <0.0001) had an intermediate or a late onset. When the surgical outcomes of SBO were evaluated, the TOS group had significantly more ( P <0.0001) blood loss and longer operation time; however, no significant difference was observed in the surgical morbidity/mortality (Clavien-Dindo classification ≧3, 11.8 vs. 14.1%, P =0.6367), hospitalization, and readmission rates between the two groups. Postoperative follow-up showed that the estimated 3-year (11.37 vs. 18.8%) and 6-year (25.54 vs. 67.4%) recurrence rates of SBO were significantly lower ( P =0.016) in the MIS group than in the TOS group. The wide adoption of MIS to treat primary CRC has led to a lower incidence, altered patterns, and reduced recurrence rates of SBO. Awareness of this new trend will help develop surgical techniques to prevent incomplete restoration of anatomical defects and bowel malalignments specifically associated with MIS for CRC, as well as facilitate timely and appropriate management of SBO complications whenever they occur.

Abnormal Vaginal Cytology after Total Laparoscopic Hysterectomy in Patients with Cervical Intraepithelial Neoplasia.

To explore the incidence of abnormal vaginal cytology after total laparoscopic hysterectomy for the treatment of cervical intraepithelial neoplasia 3, we retrospectively analyzed the medical records of patients treated at NHO Shikoku Cancer Center (Japan) in 2014-2019. The cases of 99 patients who underwent a laparoscopic (n=36) or open (n=63) hysterectomy and postoperative follow-up were examined. Abnormal vaginal cytology was detected in 13.9% (5/36) of the laparoscopic-surgery (LS) group and 14.3% (9/63) of the open-surgery (OS) group. A vaginal biopsy was performed at the physicians' discretion; one LS patient and six OS patients were diagnosed with vaginal intraepithelial neoplasia. The cumulative incidence of abnormal vaginal cytology at 3 years post-hysterectomy was 21.4% (LS group) and 20.5% (OS group), a nonsignificant difference. A multivariate analysis showed that age > 50 years was the only independent risk factor for abnormal vaginal cytology among the covariates examined including age; body mass index; histories of vaginal delivery, abdominal surgery, and smoking; and surgical approach (hazard ratio 8.11; 95% confidence interval 1.73-37.98; p=0.01). These results suggest that the occurrence of abnormal vaginal cytology after a hysterectomy may not be influenced by the laparoscopic procedure but is associated with older age.

Compare the outcomes of minimally invasive versus opentransforaminal lumbar interbody fusion in treatment lumbar spinal stenosis

Background: Minimally invasive-transforaminal lumbar interbody fusion has become an effective method to treat lumbar spinal stenosis and is widely used. This article compares the effectiveness of minimally invasive and open transforaminal lumbar interbody fusion surgery in treating lumbar spinal stenosis. Methods: From 9/2018 to 10/2022, 104 patients with lumbar spinal stenosis were treated with transforaminal lumbar interbody fusion, including 52 cases in the minimally invasive surgery group and 52 cases in the open surgery group. Parameters such as surgery time, blood loss, postoperative time, hospital stay, and complications were recorded. The Visual Analog Scale (VAS) was used to assess low back and leg pain, and the Oswestry Disability Index (ODI) was used to assess pain and functional outcome in preoperation, three months, and six months after surgery. Follow-up plain X ray were taken to evaluate the fusion after 2 years. Results: The two groups found no significant differences in age, sex ratio, and percentage of cause spinal stenosis data. Compared with the open surgery group, the minimally invasive surgery group had less intraoperative blood loss (127.50 ± 27.99 mL vs 25.12 ± 62.05 mL, P &lt; 0.001), bed immobilization time shorter (1.21 ± 0.41 days versus 2.40 ± 0.60 days, P &lt; 0.001) and shorter postoperative hospital stay (4.42 ± 0.94 days versus 6.77 ± 1.13 days, P &lt; 0.001). VAS scores of low back pain and leg pain and ODI scores of the two groups decreased statistically significantly compared to before surgery, but there was no difference between the two groups after six months. X-ray showed no significant difference in fusion of the two groups. Conclusion: Our study showed that minimally invasive transforaminal lumbar interbody fusion is a safe and effective option in treating lumbar spinal stenosis and has the advantage of less blood loss and less hospital stay compared to open surgery. Key words: Transforaminal lumbar interbody fusion (TLIF), minimally invasive spine surgery, open spine surgery, spinal stenosis.

Open and Laparoscopic Surgical Approache in Incisional Hernias: A Descriptive Analysis.

Background: Incisional hernias, occurring in 10-20% of patients post-abdominal surgery, significantly affect patient quality of life and healthcare systems. This study analyses two hernia repair methods: laparoscopic intraperitoneal onlay mesh (IPOM) and open on-lay hernioplasty. Key analysis factors include operative time, postoperative pain, complications, length of hospital stay, recovery speed, and recurrence rates, with the goal of identifying the most effective and beneficial approach for patients. Methods: We conducted a retrospective study on 70 patients with postoperative parietal defects at the Dr Carol Davila Clinical Nephrology Hospital, Bucharest, from January 2018 to December 2021. Patients underwent either laparoscopic IPOM (42 patients) or open hernioplasty (28 patients) for uncomplicated incisional hernia repair. We analyzed demographic data, comorbidities, defect size and location, previous surgeries, and surgical outcomes. Results: The laparoscopic group had a slightly shorter operative time and significantly lower postoperative pain levels, as assessed by the Visual Analog Scale. The laparoscopic approach also resulted in shorter hospital stays and quicker return to routine activities. Complications, such as seroma and hematoma, were more common in the open surgery group, but no wound infections or prosthesis rejections were observed in either group. Notably, the open surgery group showed a higher recurrence rate (11 %) compared to none in the laparoscopic group within a one-year follow-up. Conclusion: Laparoscopic IPOM for incisional hernia repair shows benefits over open hernioplasty, with less pain, shorter hospitalization, faster recovery, and lower recurrence. Its growing preference and potential for further research are highlighted.

Comparative study of tumor-free laparoscopic and open surgery in the treatment of early-stage cervical cancer.

Laparoscopic surgery for cervical cancer has the advantages of little blood loss and rapid recovery, but its therapeutic effect is still controversial. This study aims to analyze the surgical procedure and clinical efficacy of tumor-free laparoscopic radical hysterectomy without a uterine manipulator for early-stage cervical cancer, and to explore the indications of laparoscopic surgery for cervical cancer. This study was a retrospective study. The data of patients who underwent radical hysterectomy for early-stage cervical cancer admitted to Hunan Provincial Maternal and Child Health Care Hospital from July 2019 to December 2021 were collected. According to 2018 the International Federation of Gynecology and Obstetrics (FIGO) clinical staging, all patients were in IA1 with lymphovascular invasion, IA2, and IB1 stage. Among them, 45 patients underwent tumor-free laparoscopic radical hysterectomy without a uterine manipulator (laparoscopy group) and 16 patients underwent open surgery (open surgery group). Patients were followed up for 12-41 months. The differences between the 2 groups in terms of operative time, bleeding volume, extent of surgical resection, surgical complications, and prognosis were compared and analyzed. Compared to the open surgery group, the laparoscopy group had significantly shorter operation time and less intraoperative blood loss (both P<0.001). There were no significant differences between the 2 groups in terms of the length of excised uterosacral ligaments, cardinal ligaments, vagina, and the number of excised lymph nodes (all P>0.05). The incidence of postoperative complications did not differ significantly between the groups (P>0.05). No death or recurrence occurred in the 2 groups during the follow-up period. The overall survival rate and disease-free survival rate were both 100%. For early-stage cervical cancer with a diameter ≤2 cm, tumor-free laparoscopic radical hysterectomy without a uterine manipulator is safe and feasible, and the short-term outcomes is no less than that of open surgery.

Preemptive Intervention in Airflow Obstruction Status Prevents the Development of Bronchiolitis Obliterans Syndrome after Allogeneic Stem Cell Transplantation: Multicenter, Prospective Phase II Study (Chiba AFO-01)

Background: Bronchiolitis obliterans syndrome (BOS) after allogeneic hematopoietic stem cell transplantation (allo-HCT) is recognized as pulmonary chronic graft-versus-host disease (GVHD), a progressive, irreversible, and sometimes fatal complication. Periodic pulmonary function testing (PFT) for early diagnosis and timely therapeutic intervention is essential. However, effective monitoring and adequate treatment strategy for BOS have not been established. The airflow obstruction (AFO) criteria (predicted FEV1 second decreased by 5% a year or more, and FEV1-second rate &amp;lt;80%) had proposed to detect of a precursor of BOS, and even at AFO status, it was confirmed that increasing the risk in mortality of 2.3-fold (95% CI, 1.6- 3.3; P &amp;lt; 0.001) (JW Chien et al. Am J Respir Crit Care Med. 2003). In our single-center retrospective analysis, 67.2% of AFO patients progressed to BOS, and similarly, the AFO was associated with poor survival (Nakao et al., in submission). Although immunosuppressive agents, especially steroids, are usually administered or augmented for new-onset BOS, sufficient response has not necessarily been obtained. The feasibility study with inhaled fluticasone, azithromycin, and montelukast (FAM) with a brief steroid pulse had been reported, which was well tolerated; however, about one-third were a failure at 6 months, showed efficacy was extremely limited in advanced BOS. From these findings, we hypothesized that close monitoring and early intervention from the diagnosis of AFO using inhaled steroid long-acting β2-agonist budesonide/formoterol fumarate hydrate, clarithromycin, and montelukast (BCM) triplet therapy, could avert the progression to BOS. We conducted a multicenter, single-arm, open-label, prospective phase II study (Chiba AFO-01). This study was approved by the certified clinical research review board at Chiba University Hospital. (jRCTs031180338) Patients and Method: PFT was performed before and every 3 months after allo-HCT for 2 years, and from the time when the AFO criteria were met, BCM therapy was started and continued for 1 year. BOS and GVHD diagnoses were made according to the 2014 NIH Consensus Development Project on Criteria for Clinical Trials (BBMT 2015). The primary endpoint was the inhibition rate of BOS progression, and the secondary endpoints were AFO incidence rate, recurrence rate, survival rate, GVHD, intervention rate of systemic immunosuppressive therapy, and safety of BCM therapy. The statistical analysis plan considered it effective if the incidence of BOS with triple treatment was less than 65% with a two-sided P-value &amp;lt;0.10. Results: Between June 2016 and June 2018, 85 patients were enrolled, and 84 were included in the analysis. One was excluded from the analysis due to deviation. Fifteen of eighty-four (17.9%) met AFO criteria at the median of 178 days (63-728) after allo-HCT, and the 2-year cumulative incidence of AFO was 26.1%. Fourteen with AFO received the BCM treatment. Three patients developed BOS (0, 182, 420 days after onset of AFO). The BOS progression rate was 21.4% (95% CI: 4.7-50.8%), which was significantly below the threshold (65%) set by historical control, had demonstrated the inhibitory effect on BOS progression significantly ( P&amp;lt;0.001). No significant difference was observed in the relationship between AFO and primary disease, stem cell source, pretreatment, and chronic GVHD incidence compared to the non-AFO group. At the AFO diagnosis, 80% had not developed or concurrently diagnosed with chronic GVHD. During the study period, 80% had developed an active chronic GVHD in the AFO group and 54.2% in the non-AFO group. The BCM therapy was feasible, and 9 completed the treatment. Five were discontinued due to the development of IPS in 2, disease progression in 1, bacterial pneumonia in 1, and patient's preference in 1. No difference was observed between the two groups in 2-year OS (AFO 86.7% vs non-AFO 94.2%, Log-rank P=0.55) Conclusion: We revealed the target timeframe for PFT monitoring for early identifying patients at risk for subsequent BOS after allo-SCT. PFT monitoring and therapeutic intervention with BCM therapy for patients with AFO could improve outcomes. The therapeutic intervention from the BOS diagnosis is too late to improve prognosis, and early therapeutic intervention is essential when respiratory function decline is observed, regardless of the presence or absence of chronic GVHD.

Marrow Hypercellularity Does Not Exclude the Diagnosis of Essential Thrombocythemia (ET)

Background: The 2022 WHO criteria do not list bone marrow cellularity as a criterion for ET diagnosis (dx) 1, but a review discussing the International Consensus Classification criteria states that the marrow should be normocellular for age, with rare cases of mild hypercellularity 2. The ELN also cited normocellularity as a key factor in differentiating ET from polycythemia vera (PV) or prefibrotic myelofibrosis (MF), further suggesting that normocellularity is the expected standard in ET 3. However, we encountered a number of cases in our hematology practice with increased cellularity in bona fide ET patients (pts). Therefore, we decided to more systematically review the marrow cellularity and its prognostic impact. Methods: Medical records were queried for pts with ET per the ICD, versions 9-10. The dx of ET per WHO 2022 was confirmed by manual review. Cases lacking marrow biopsy were excluded. Structured query language was used for automated extraction of clinical, lab, and molecular findings. We utilized our previously described natural language processing pipeline to extract cellularity information from marrow reports 4. All hematopathology reports of hypercellular marrows were manually reviewed by 3 observers for confirmation and a randomly selected subset of the core and clot sections were reviewed for histomorphology and cellularity by 2 expert hematopathologists and 1 histomorphologist, blinded to pt age and clinical information prior to their review. Quantitative cellularity was determined independently and then congruently for consensus. Qualitative cellularity was defined using (100-age) ± 20% as the normal range with increases above this range considered hypercellular for age. Disease progression was defined as either progression to post-ET MF (PETMF) or direct transformation to acute myeloid leukemia. Transformation to PV was defined as pts with a JAK2 mutation for whom PV was thoroughly excluded at the time of ET dx but who developed absolute erythrocytosis and met the PV WHO diagnostic criteria later in their disease course. We performed univariable and multivariable analysis of progression, PV transformation, thrombosis and mortality risk using Cox proportional-hazards models. Overall (OS), progression-free (PFS), PV-free (PVFS) and thrombosis-free (TFS) survival were estimated using Kaplan-Meier methods. Results: 382 pts met WHO defined ET with marrow dx, of which 145 had pre-treatment diagnostic marrows available for review at Weill Cornell. In the other 237, the diagnostic biopsies had either been performed after treatment was initiated or only the report was available. Thirty-three (23%) were described as hypercellular and 112 (67%) were not. Review of 20 randomly selected marrows from the hypercellular group confirmed age-adjusted hypercellularity ranging from 30 to 80%. The hypercellular pts were significantly older at dx compared to those without hypercellularity (59 vs 50 yrs, p &amp;lt;0.001, Table 1). We identified no other significant differences in blood counts at dx, sex, driver mutation or thrombosis history between the groups. Univariate and multivariate analyses demonstrated no significant difference between the groups in PFS (HR 1.29, p=0.871), TFS (HR 1.39, p=0.671) or OS (HR 0.50, p=0.487) using age, thrombosis history and sex as covariates. A Cox model could not be generated for PVFS due to the low number of events. The 15-year PFS for pts with hypercellularity vs those without was 97% and 94% respectively ( p=0.56, Figure 1), 15-year PVFS was 100% and 67% respectively ( p=0.12), 15-year TFS was 79% and 87% respectively ( p=0.53) and 15-year OS was 84% and 81% respectively ( p=0.74). Conclusion: Our data to date suggests that hypercellularity is of importance diagnostically but not prognostically. Nearly a quarter of our pts with WHO ET had marrow that was hypercellular for age at dx. Pts with increased marrow cellularity tended to be older but were clinically indistinguishable from the remainder in terms of driver mutation, blood counts and thrombosis history. Univariate and multivariate analyses demonstrate that hypercellularity does not confer increased risk of progression, thrombosis or mortality. Thus, hypercellularity alone should not be used as a factor for excluding ET dx.

2446. Effect of the Implementation of a Fluconazole Prophylaxis Protocol on the Incidence of Invasive Fungal Infection in High-Risk Neonates

Abstract Background Invasive fungal infection (IFI) is one of the most important causes of morbidity and mortality in the neonatal intensive care unit. International societies have supported the use of fluconazole prophylaxis for neonates weighing &amp;lt; 1000 grams, but administration to other high-risk patients remains controversial. An institutional fluconazole prophylaxis guideline was implemented in December 2020 to include two other groups of neonates. Methods One hundred thirty infants who were admitted at the NICU from January 2020 to January 2022 and fulfilled one of the following criteria: weight of &amp;lt; 1000 grams (Group A), weight of ≤1500 grams and on broad-spectrum antibiotics (Group B), or weight of &amp;gt;1500 grams and on prolonged nil per os (NPO) (Group C) were included in the study. They were divided into two groups: those who were born prior to the implementation of the protocol (January to December 2020) and not given fluconazole prophylaxis, and those born after (January 2021 to January 2022) and given prophylaxis. The primary outcome was the development of IFI. Results A total of 130 infants were included in this study with 21 (5 control, 16 prophylaxis), 69 (28 control, 41 prophylaxis), and 40 (16 control, 24 prophylaxis) patients in Groups A, B, and C, respectively. There were no significant differences in the development of IFI among the groups (Group A: control - 40%, prophylaxis - 62%; Group B: control - 21.4%, prophylaxis - 22%; Group C: control - 29.2%, prophylaxis 31.5%) with a p-value of &amp;gt; 0.05. The presence of a central vascular access line, endotracheal tube, placement on NPO, histamine H2-blockers, and necrotizing enterocolitis were associated with the development of IFI. Candida parapsilosis comprised 60% of isolates. All isolates had 100% susceptibility to fluconazole. Jaundice developed in 3.7% of patients given fluconazole, with elevations in AST, ALT, and TB. Incidence of fungal infection in high-risk neonates There were no significant differences in the development of IFI among the three high-risk groups, with p-value of &amp;gt; 0.05. Conclusion Invasive fungal infection remains a heavy burden to high-risk neonates. The protocol at present does not significantly prevent the occurrence of IFI. There is a need to revise the protocol to include the presence of a combination of multiple risk factors (central line, endotracheal tube, prolonged NPO, H2-blockers, and necrotizing enterocolitis) before initiating fluconazole prophylaxis. Disclosures All Authors: No reported disclosures

Robotic Vaginal Cuff Closure During Radical Hysterectomy for Early-Stage Cervical Cancer: The Bruges Method.

The only randomized trial (LACC trial, Laparoscopic Approach to Cervical Cancer), published in 2018, comparing the oncologic outcomes of minimally invasive and open surgery in early-stage cervical cancer, has shown inferior disease-free and overall survival for minimally invasive surgery. Subsequent large retrospective cohort studies of centers with long-standing experience in minimally invasive surgery and large nationwide cohort studies have shown that both the laparoscopic and robotic approaches have similar survival outcomes as the open surgery group in the LACC trial. Important protective measures to avoid tumor spillage in the peritoneal cavity during colpotomy were the closure of the vaginal cuff and avoiding the use of a uterine manipulator. Several methods have been described to close the vaginal cuff, mainly by a vaginal approach. Here we describe with a video a new technique of vaginal cuff closure during a robotic-assisted radical hysterectomy. During the robotic procedure, a purse string barbed suture is placed through the vaginal walls in order to close the vagina prior to colpotomy. The technique is a feasible, relatively fast, and easy-to-learn addition to the robotic radical hysterectomy procedure in early-stage cervical cancer.

OGC O01 Minimally invasive or open oesophagectomy for localised oesophageal cancer: long-term follow-up of the ROMIO pragmatic randomised controlled trial

Abstract Background Patients with localised oesophageal cancer are frequently offered neoadjuvant treatment and surgery, with the benefit of improved survival but an expected at least short term negative impact on quality of life (QoL). Minimally invasive surgical techniques may reduce the QoL impacts by reducing tissue damage. The ROMIO study compared hybrid with open oesophagectomy, to test the hypothesis that hybrid allows faster recovery whilst maintaining the survival benefit of surgery. We have previously reported no evidence of a difference in early complications or recovery of physical function. Here we present the results of the comparison of longer term QoL and survival. Methods A pragmatic multi-centre randomised controlled trial was conducted in nine UK cancer centres. Patients with localised adenocarcinoma or squamous cell cancer were selected by multi-disciplinary teams for oesophagectomy with or without neoadjuvant treatment. Patients were randomly allocated to laparoscopic abdominal surgery and thoracotomy (hybrid) or open oesophagectomy. Surgery was quality assured by provision of a protocol, pre-operative video assessment of the 40 participating surgeons, and intra-operative photographs of key surgical components. Here we report on survival, and patient reported outcomes measured using the EORTC QLQ-C30, over 2 to 3 years post-randomisation. Results At enrolment 469 (89%) of 527 participants had an adenocarcinoma, 371 (71%) had a clinically staged T3 or T4a tumour, 296 (56%) had clinically positive nodes, and 438 (83%) underwent neoadjuvant treatment. Kaplan-Meier estimates of survival at 24 months were 66% in the hybrid surgery group (95% confidence interval 60% to 71%) and 65% in the open surgery group (95% confidence interval 57% to 69%) with the difference between the two groups being consistent with chance. Preliminary analyses did not provide evidence of a difference in patient reported quality of life following the two surgical approaches. Conclusions In contrast to the previous MIRO study, the ROMIO study has not identified any differences between hybrid and open surgery in complications, short-term recovery of physical function, or survival and quality of life over two to three years post-randomisation. Both approaches remain common in UK practice, with ROMIO providing evidence of their safety. Potentially, a fully minimally invasive approach, as investigated in the ROMIO phase 2b substudy and the TIME study, is required to realise the potential benefits of minimally invasive approaches.

Outcomes of Laparoscopic Surgery in Very Elderly Patients with Colorectal Cancer: A Survival Analysis and Comparative Study.

(1) Background: Colorectal cancer (CRC) is a global health concern, particularly among the elderly population. This study aimed to assess the impact of laparoscopic surgery on CRC patients aged ≥80 years. (2) Methods: We conducted a retrospective analysis of prospectively collected data from consecutive CRC patients who underwent surgery at our institution between July 2018 and July 2023. The patients were categorized into three groups: those aged over 80 who underwent laparoscopic surgery (Group A), those aged over 80 who underwent open surgery (Group B), and those under 80 who underwent laparoscopic surgery (Group C). We examined various clinical and surgical parameters, including demographic data, medical history, surgical outcomes, and survival. (3) Results: Group A (N = 113) had shorter hospital stays than Group B (N = 23; p = 0.042), with no significant differences in complications or 30-day outcomes. Compared to Group C (N = 269), Group A had higher comorbidity indices (p < 0.001), more emergency admissions, anemia, low hemoglobin levels, colonic obstruction (p < 0.001), longer hospital stays (p < 0.001), and more medical complications (p = 0.003). Laparotomic conversion was associated with obstructive neoplasms (p < 0.001), and medical complications with ASA scores (p < 0.001). Both the medical and surgical complications predicted adverse 30-day outcomes (p = 0.007 and p < 0.001). Survival analysis revealed superior overall survival (OS) in Group A vs. Group B (p < 0.0001) and inferior OS vs. Group C (p < 0.0001). After a landmark analysis, the OS for patients aged 80 or older and those under 80 appeared to be similar (HR 2.55 [0.75-8.72], p = 0.136). (4) Conclusions: Laparoscopic surgery in very elderly CRC patients shows comparable oncological outcomes and surgical complications to younger populations. Survival benefits are influenced by age, comorbidities, and medical complications. Further prospective multicenter studies are needed in order to validate these findings.